BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* BLADELESS TROCAR WITH STABILITY SLEEVE

    MDR report key: 1821269 · Received August 31, 2010

    Report

    Report Number
    3005075853-2010-04960
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    July 30, 2010
    Report Date
    August 9, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED WITH GAUZE AROUND THE UNIVERSAL SEAL AND SLEEVE. ONCE THE GAUZE WAS REMOVED, THE DEVICE WAS FUNCTIONALLY LEAK TESTED AND PASSED. THE DEVICE WAS FULLY FUNCTIONAL ACCORDING TO THE MANUFACTURING REQUIREMENTS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE CARDIOVASCULAR UNIT MANAGER THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH CREATININE RISING FROM 1.2 TO 2.1 AND POWER VALUES SLOWLY INCREASING. THE PATIENT WAS INTUBATED AND A RAMP SPEED STUDY WAS PERFORMED IN THE ICU WHICH SHOWED MINIMAL LEFT VENTRICULAR DECOMPRESSION WHEN THE PUMP SPEED WAS INCREASED FROM 8800 TO 10000 RPMS. THE AORTIC VALVE WAS OPENING EVERY BEAT. A LV GRAM WAS PERFORMED AND DYE SWIRLED IN THE LEFT VENTRICULAR; HOWEVER, MINIMAL DYE WENT THROUGH THE AORTIC VALVE AND OUTFLOW GRAFT TO THE AORTA. A PUMP EXCHANGE WAS PERFORMED DUE TO SUSPECTED THROMBUS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE DEVICES LEAKED. BMI43, USAGE CO2 300 LITER. A TOTAL OF FOUR DEVICES LEAKED. EVEN WHEN THEY WERE NOT USING, YOU COULD HEAR THE CO2 COMING OUT. STICKERS ON THE DEVICES, GAUZE AROUND THE DEVICES, AND ROTATION OF THE DEVICES HAD A LITTLE EFFECT BUT THE LEAKAGE STILL CONTINUED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** XCEL* BLADELESS TROCAR WITH STABILITY SLEEVE LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA G4TC2W

    Patients

    Seq Age Sex Outcome Treatment
    1